Clinical Trials Logo

Clinical Trial Summary

After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.


Clinical Trial Description

Patients with late fibrovascular sequelae of radiation or of combined radiation and surgery, with quantifiable symptomatology or disability, will be eligible for this trial. This protocol is designed as an open label one arm study. (A placebo controlled randomized trial was approved by the IRB but after extensive negotiation, drug and placebo in slow release formulation will not be provided by the manufacturer). Up to fifty patients will be recruited. After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.

In addition to symptomatic objective and subjective response, blood and urine will be collected for TNF, TGF-beta, and FGF. Cutaneous blood flow and collagen subtyping will be performed on a subset of patients using Laser Doppler, functional MRI techniques and subcutaneous tissue biopsies. We will examine for correlation between clinical response and these biological responses. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00001437
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 2
Start date June 1995
Completion date March 2000

See also
  Status Clinical Trial Phase
Recruiting NCT05570058 - Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03979417 - Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets
Completed NCT02408744 - Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease Phase 1/Phase 2
Active, not recruiting NCT00148837 - Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis Phase 2
Recruiting NCT05661123 - Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis N/A
Recruiting NCT04795570 - Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors
Active, not recruiting NCT05075785 - Covid-19 Respiratory Sequelae French Cohort
Recruiting NCT03308916 - Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers N/A
Recruiting NCT05459259 - Physiotherapy for Arthrofibrosis Following Knee Replacement.
Enrolling by invitation NCT01483248 - Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis Phase 1/Phase 2
Completed NCT00001729 - Combination Drug Therapy for Patients With Hepatitis C Phase 3
Completed NCT02049307 - Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial Phase 2
Active, not recruiting NCT05685823 - The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle
Completed NCT00744939 - Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist Phase 4
Completed NCT00252642 - Peginterferon Alpha-2a Maintenance Therapy for Portal Hypertension in Patients With Hepatitis C N/A
Recruiting NCT04934202 - Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France
Completed NCT02604862 - Imaging FIB ONE in the Human Lung Using Endomicroscopy Early Phase 1
Completed NCT02774161 - B-mode Ultrasound Imaging in Detecting Early Liver Cancer N/A
Active, not recruiting NCT01246388 - Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy N/A
Completed NCT02161952 - Pirfenidone, an Antifibrotic and Antiinflammatory Drug Phase 2